You can’t read the paper these days without seeing another ad for a chiropractic clinic advertising a local seminar for amniotic or cord-blood stem cells. It’s ridiculous because there are no living and functional stem cells in the products these practices use, and simply by making the claim of live stem cells, the practice is marketing an illegal drug product. Hence, I have created a video to arm consumers with information when they go to these seminars. This week on Facebook, a patient who watched our video and who was saved from the scam posted her comments, so let’s delve into what she said.
“Becky-I’ve been researching orthopedic stem cell procedures for several months and decided to attend a seminar in my town. Fortunately, I watched this video and knew what questions to ask. The D.C. making the presentation asked me to talk to him after the seminar and immediately began telling me why their cells from Predictive Biotech in Utah were far superior than Regenexx. He also told me that Dr. Centano wanted to use their stem cells because Regenexx was having problems with the stem cells they harvested from patients. I found it odd that he brought up Regenexx and Dr. Centano since I had not mentioned either. He later emailed me a couple of white papers comparing cod cells to adult stem cells, but those papers really had nothing to do with Predictive Biotech. I contacted the company to ask about the viability of their stem cells after the cells had been thawed and readied for injections. I was given another paper that was not specific to their lab.
Long story short, I set up a consultation with a Regenexx doctor. What a difference! The first thing Dr. Rigert wanted to discuss was my overall health and habits. Then we talked about my expectations. After going over my MRIs and considering my physical health, I was told I was a good candidate, but the doctor was very honest about what I could realistically expect. I’m looking forward to starting my procedure in the coming week. Thankfully Regenexx provided me with information that kept me from falling for a really good sales pitch!”
Here’s our video on stem cell seminars and the top questions to ask:
This patient came across the typical bait and switch common at these seminars. Given that these are more sales than medical events, the patient is provided with a false narrative to not use their own stem cells. They are told they don’t have enough stem cells or that their stem cells are too old. I have already reviewed the fallacy behind these concepts, see the video below:
Of course, the biggest false negative of the night is that there are any living and functional stem cells in these products. The IOF has tested many amniotic products and found none. This isn’t surprising, as the way these products are collected, processed, and inappropriately thawed in a doctor’s office would almost guarantee that few viable cells could be there. We are now working with a third-party university to test even more samples of these products. To learn more about why we’re not finding living and functional cells in these products, see below:
Another false narrative in these seminars is that these amniotic and cord-blood “stem cell” products are FDA approved. In fact, they’re not. All tissue vendors go through a 45-minute FDA registration for a product that cannot legally contain any living cells. Hence, they are regulated to be dead tissue products:
One of the companies discussed by Becky in her post is Predictive Biotech. The chiropractor made a claim that somehow there were living stem cells in the products made by this company. There was also a claim made that somehow we wanted to use the “cells” manufactured by this company. Becky was also given reports on these cells, which she quickly saw through. So what’s true here?
First, I have already reviewed the very poorly done viability tests on the Corecyte product made by this company. These all lack the one test that would actually tell if there were any surviving and functional mesenchymal stem cells (MSCs). This is the ability of these cells to grow on culture, as if they can’t grow, no matter what a simple viability test shows, they are damaged goods.
Second, we asked Predictive for a sample of this product to test in late 2016. Our goal has always been the same. Before the Regenexx network can adopt the use of a product, we must independently test that product in our research lab. If it passes muster, we’ll consider purchasing the product. Given that a sales rep for Predictive had approached a university-based colleague of mine who called me told me of this rep’s claims of millions of live stem cells in every vial, we wanted to vet that claim. Curiously, Predictive refused to send us a sample for testing.
Understanding FDA Regulation of All Cell Products
One of the things that many people don’t understand is that FDA’s regulation of cells all revolves around marketing. So for all intents and purposes, the FDA wouldn’t care whether or not Predictive’s product actually had live and functional stem cells, only whether they made the claim that it has live cells. Why? Because a claim of live cells that are capable of repairing or healing tissue is all it takes for the company to get bumped from a 45-minute free online tissue registration to a 10-year full FDA-approval process costing hundreds of millions of dollars. Predictive has the former and wants to avoid the latter.
Once the FDA moved Predictive’s products into the cell-drug category based solely on the claims of live MSCs and took the products off the market, then it would care intensely whether or not there are live cells. In pre-FDA trials testing, the company would need to spend millions just classifying what cells were viable, whether they could survive in culture, whether assays showed the cells could function, and so on. Then the company would have to spend tens to hundreds of millions testing these products in real clinical trials on real patients over many years. That cost would be per indication (i.e., one for knee arthritis and a separate one for hip arthritis, etc.).
However, if Predictive makes this claim without full FDA cell-drug approval (whether or not, in reality, there are any live stem cells), they are automatically an illegal cell-drug product that has not obtained proper FDA approval. To understand this, watch the video below:
If we look at Predictive’s website, this is what we find:
“CoreCyte™ is a minimally manipulated human tissue allograft derived from umbilical cord tissue for homologous use. CoreCyte™ is intended to supplement and replace damaged or inadequate connective tissue and cells. CoreCyte™ contains a variety of growth factors, cytokines, hyaluronic acid and mesenchymal stem cells.
Currently MSCs are being isolated from the patients’ own bone marrow or adipose (fat) tissue. The differentiating factor is that umbilical cord tissue MSCs are more fit and have a much higher rate of proliferation when compared to MSCs derived from either adipose or bone marrow.”
All of this advertising on the Predictive website is not FDA compliant and classifies their product as a 351 cell drug that has no such FDA approval. Basically, an illegally marketed, misbranded, and adulterated drug product. Again, it doesn’t matter if all the cells in this product are functionally dead—merely the claim creates the drug event.
The Chiropractor’s Liability
First, as a health-care provider, regardless of what Predictive’s website says, the chiropractor parroting these claims of live mesenchymal stem cells and holding seminars to promote same is ultimately also liable. What he likely doesn’t know about is a portion of the FDCA that states that if he buys a misbranded and adulterated drug product, he can be prosecuted by the feds. See video below:
Do These Dead Amniotic and Cord “Stem Cell” Products Have Any Legitimate Use?
While it’s fraud to claim that products regulated to be dead have living and viable cells, some amniotic products may have a legitimate use for their growth factors. The problem here is that we have tested only one of these products that has enough growth factors to make us want to test it further and possibly use it in select patients. We’re discussing things with that company now.
The upshot? First, I’m really glad this patient read our key questions to ask at an amniotic stem cell webinar post. Second, it’s amazing the amount of graft that’s occurring out there in these chiropractic-led seminars. Third, if Predictive Biotech wants to have its products tested by a third-party university lab involved in MSC research to see if they actually have mesenchymal stem cells that can culture and survive, we’ll arrange for that testing at no cost to the company. Finally, we’re grateful to Becky for posting her experiences on Facebook!
Here’s a follow-up post from Becky:
“I’m the Becky in the story. I can’t stress enough the importance of educating yourself on any medical procedure. Doing so is the first step in taking charge of your own healthcare.
The chiropractor at the seminar I attended was very persuasive. Even knowing what I do, I wanted to believe him. My guess is these guys study up on persuasion techniques. I’m a political consultant and trust no one but my husband without empirical evidence- and he still got to me on a certain level. Had I not been armed with facts, I would likely have wasted thousands of dollars.
I have a great deal of respect for most chiropractors and have benefitted greatly from regular chiropractic care. I avoid pharmaceuticals and surgical procedures whenever possible. However, there is a scope of practice for all healthcare providers and they should stay within the parameters of their particular discipline.
I had a lady come up to me after the seminar who said she wanted me to go with her to her appointment. Knowledge is power folks.”
My comment: I, too, have great respect for chiropractors. I routinely work with many in my area as trusted colleagues. However, Becky brings up a great point, the chiros running these seminars are way out of their training and experience base. They are taking what should be evolving into a legitimate field of medical study and being advanced by serious physicians everywhere and exploiting a bad copy of a copy of a copy of the real procedure and hyping what’s possible. For example, in these seminars, you’ll find no candidacy grading, ridiculous statements that advanced knee arthritis patients can expect robust cartilage growth, and high-pressure sales tactics like those discussed by Becky. So instead of contributing to moving a promising field forward with discipline and rigor, they are harming the concept of regenerative medicine with an undisciplined and sloppy approach to these procedures.